Cleared Traditional

MAXXUS (K924498) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K924498 · GE Medical Systems · Radiology device
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Dec 1992
Decision
90d
Days
Class 2
Risk

K924498 is an FDA 510(k) clearance for the MAXXUS. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by GE Medical Systems (Milwaukee, US). The FDA issued a Cleared decision on December 3, 1992 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1200 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K924498 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 1992
Decision Date December 03, 1992
Days to Decision 90 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 107d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KPS System, Tomography, Computed, Emission
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1200
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - KPS System, Tomography, Computed, Emission

All 177
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K924498.
MAGELLAN
K940300 · GE Medical Systems · Mar 1994
GCA-7200A
K931297 · Toshiba America Medical Systems, In.C · Jul 1993
CORT-EX
K926133 · General Electric Co. · Jun 1993
ARGUS PET SYSTEM
K923309 · GE Medical Systems · Sep 1992
CARDIAC FIRST PASS ANALYSIS
K921777 · GE Medical Systems · Aug 1992
GE 4096 PLUS & GE 2048
K914267 · GE Medical Systems · Jul 1992